PMA P080012S030
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S030
- Product code
- LKK
- Decision date
- 2016-01-12
- Classification
- Pump, Infusion, Implanted, Programmable
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- APPROVAL FOR UPDATING THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM SOFTWARE TO VERSION 1.03.2. THE SOFTWARE UPDATE CONSOLIDATES THE CONFIGURATION DEVICE SOFTWARE WITH THE CLINICIAN PROGRAMMER.
Current openFDA PMA Record#
- Device
- PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
- Applicant
- Infusyn Therapeutics, LLC
- PMA number
- P080012
- Supplement
- S030
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2016-01-12
- Decision code
- APPR
- Date received
- 2015-10-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPDATING THE PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM SOFTWARE TO VERSION 1.03.2. THE SOFTWARE UPDATE CONSOLIDATES THE CONFIGURATION DEVICE SOFTWARE WITH THE CLINICIAN PROGRAMMER.